Focale 500

Monotherapy of partial onset seizures w/ or w/o secondary generalization in adults & adolescents from 16 yr w/ newly diagnosed epilepsy. Adjunctive therapy of partial onset seizures w/ or w/o secondary generalization in adults, adolescents & childn from 4 yr w/ epilepsy; myoclonic seizures in adults & adolescents from 12 yr w/ juvenile myoclonic epilepsy; primary generalized tonic-clonic seizures in adults, adolescents & childn from 6 yr w/ idiopathic generalized epilepsy.

Monotherapy Adult & adolescent from 16 yr Initially 250 mg bid, increased to 500 mg bid after 2 wk. May be further increased by 250 mg bid every 2 wk depending upon clinical response. Max dose: 1,500 mg bid. Add-on therapy Adult ≥18 yr, adolescent 12-17 yr weighing ≥50 kg Initially 500 mg bid (may start on 1st day of treatment). May be increased up to 1,500 mg bid depending upon clinical response. Dose changes can be made in 500 mg bid increased or decreased every 2-4 wk. Childn 4-11 yr & adolescent 12-17 yr weighing <50 kg Initially 10 mg/kg bid. May be further increased up to 30 mg/kg bid depending upon clinical response & tolerability. Dose changes should not exceed increments or decrements of 10 mg/kg bid every 2 wk. Lowest effective dose should be used. Dose recommendations: Childn & adolescent weighing from 50 kg Initially 500 mg bid. Max dose: 1,500 mg bid, 25 kg Initially 250 mg bid. Max dose: 750 mg bid, 20 kg Initially 200 mg bid. Max dose: 600 mg bid, 15 kg Initially 150 mg bid. Max dose: 450 mg bid. Switching from or to oral levetiracetam Initial total daily dose of IV should be equiv to daily dose & frequency of oral levetiracetam. May switch back to oral levetiracetam at equiv daily dose & frequency of administered IV after completion of IV treatment. Dose adjustment: Renal impairment: Adult & adolescent weighing >50 kg w/ normal CrCl (>80 mL/min/1.73 m²) 500-1,500 mg bid, mild CrCl (50-79 mL/min/1.73 m²) 500-1,000 mg bid, moderate CrCl (30-49 mL/min/1.73 m²) 250-750 mg bid, severe CrCl (<30 mL/min/1.73 m²) 250-500 mg bid, ESRD undergoing dialysis 750 mg loading dose on 1st day of treatment, followed by 500-1,000 mg once daily. Supplemental dose of 250-500 mg is recommended following dialysis. Childn & adolescent weighing <50 kg w/ normal CrCl (>80 mL/min/1.73 m²) 10-30 mg/kg bid, mild CrCl (50-79 mL/min/1.73 m²) 10-20 mg/kg bid, moderate CrCl (30-49 mL/min/1.73 m²) 5-15 mg/kg bid, severe CrCl (<30 mL/min/1.73 m²) 5-10 mg/kg bid, ESRD undergoing dialysis 15 mg/kg loading dose on 1st day of treatment, followed by10-20 mg/kg once daily. Supplemental dose of 5-10 mg/kg is recommended following dialysis. Severe hepatic impairment Reduce 50% of daily maintenance dose when CrCl is <60 mL/min/1.73 m².

May be taken with or without food: Swallow w/ sufficient liqd.

Hypersensitivity to levetiracetam or other pyrrolidone derivatives.

Permanently discontinue & consider alternative therapy if manifestations suggestive of SJS or TEN occur; if alternative etiology cannot be identified. Discontinue at 1st sign of rash (unless clearly not drug-related); immediately & seek medical attention if signs or symptoms of anaphylaxis or angioedema occur. Avoid abrupt w/drawal. Increased risk of suicidal behavior or ideation. Hematologic abnormalities (eg, decreased RBC, WBC, & neutrophil counts); agranulocytosis, leukopenia, neutropenia, pancytopenia, & thrombocytopenia. Hypotension, hives, rash, resp distress, facial swelling, & swelling of tongue, throat, & feet may occur at any time during therapy. Patients w/ epilepsy, psychiatric disorders (eg, bipolar disorder, depression, anxiety) & other conditions (eg, migraine, neuropathic pain); liver & renal disease. Monitor patients for adverse neuropsychiatric effects eg, somnolence & fatigue, coordination difficulties & behavioral/psychiatric abnormalities. Perform CBC in patients w/ any signs or symptoms of hematologic abnormalities eg, severe weakness, pyrexia, recurrent infections, coagulation disorders. Not to drink alcohol or anything mixed w/ alcohol while on treatment. May impair ability to drive or operate machinery. Renal & severe hepatic impairment. May cause teratogenic effects on fetus; gradually decrease plasma levels of levetiracetam in pregnant women during 3rd trimester. Closely monitor during pregnancy & throughout postpartum period, especially if dosage is adjusted during pregnancy. Lactation. Behavioral abnormalities eg, paranoia, confusional state & increased aggression in ped 4-16 yr w/ partial onset seizures. Monitor ped <4 yr for increased diastolic BP during therapy. Ped <1 mth for management of partial onset seizure; <12 yr for management of myoclonic seizures; <6 yr for management of primary generalized tonic-clonic seizure; <16 yr for levetiracetam in NaCl inj. Monotherapy in childn & adolescents <16 yr.

Somnolence, asthenia, headache, infection, dizziness, pain, pharyngitis, depression, nervousness, rhinitis, anorexia, ataxia, vertigo, amnesia, anxiety, emotional lability, hostility, paresthesia, increased cough, sinusitis, diplopia. Vomiting, nasopharyngitis, fatigue, aggression, upper abdominal pain, nasal congestion, decreased appetite, pharyngolaryngeal pain, abdominal behavior, irritability, diarrhea, lethargy, insomnia, head injury, agitation, constipation, flu, contusion, fall, altered mood, ear pain, conjunctivitis, gastroenteritis, joint sprain, arthralgia, neck pain, sedation, labile affect, confusional state & mood swing. Nausea.

Increased clearance w/ hepatic enzyme-inducing anticonvulsants eg, carbamazepine (ped).

Anticonvulsants

N03AX14 - levetiracetam ; Belongs to the class of other antiepileptics.

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